The passing of surgical suture through a patient's skin and into a body cavity is done during laparoscopic surgery (i.e., minimally invasive surgery) through relatively small incisions, usually about one centimeter or less in length. Since this technique offers a number of distinct advantages to the patient (e.g., shorter recovery times, and reduced pain, hemorrhaging, scarring, etc.), there have been a substantial number of surgical instruments developed to accommodate this type of procedure.
These instruments are typically a sharp, pointed, grasping device with the ability to puncture the skin of a body cavity and a fatty subcutaneous layer. However, these devices pose a danger to the patient by introducing a sharp object into a cavity where they inadvertently, and not infrequently, cause injury to tissue and organs that were not the subject of the procedure. In fact, one patient safety indicator rating as to the frequency of inadvertent punctures/lacerations is maintained by the Agency for Healthcare Research and Quality—its PSI-15 rating—which is available on the corresponding government web site. Also, with respect to laparoscopic procedures where two to five trocars (access points) are typically used, the FDA had issued a report on injuries related to such medical devices. The U.S. Food and Drug Administration had maintained a database of fatal and non-fatal injuries associated with trocar insertions, its MAUDE (Manufacturer and User Facility Device Experience) database, which served as a basis for the report (see also, “Surgical Pitfalls: Prevention and Management,” by Stephen R. T. Evans, Saunders, 2008, pp. 97-100).
One such device is shown by U.S. Pat. No. 5,618,290 to Toy, the disclosures of which are incorporated herein by reference. The Toy device has a pointed end located distally from a needle shaft that could inadvertently puncture an organ or other tissue during the suturing process.
Accordingly, there is a need for an improved puncturing/suturing device that provides an added degree of safety with respect to the accidental perforation of organs and tissue during laparoscopic procedures. The present invention provides a solution to this long-felt but unmet need. The present invention, which can retract for insertion into the abdominal cavity and re-emerge and lock into place for patient safety as it enters the patients' intra-abdominal space, may also be utilized in alternate applications. The present invention may also be used as an added safety feature in a Veress Needle (needle and cannula device that enters the abdominal cavity percutaneously and then allows for CO2 gas to enter the abdominal space). Also, the creation of micro-laparoscopic instruments can utilize the retraction, re-emersion and locking feature for both percutaneous entry into the abdominal cavity and utilization of the instruments in the abdominal space. These laparoscopic instruments may include 32 cm×3 mm with distal ends that could have several instrument types, including blunt graspers, Maryland dissectors, blunt dissectors, clip appliers, monopolar or bipolar energy sources and Metzenbaum scissors.